Zimmer Orthopaedic Surgical Products Recalls
Showing 1-3 of 3 recalls
Pulsavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-420-00,10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
Zimmer notified their customers via an Urgent Device Recall letter dated January 8, 2008. The letter requests each customers to inventory their stock. If any recalled product is located the customer is to notify Zimmer via fax and a replacement part will be shipped to them.
Zimmer Orthopaedic Surgical Products, Disposable Cuff, Dual Port, Double Bladder Cuff, Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.
The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
Consignees were notified by letter on 02/11/2005.
Zimmer Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.
The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.